Senior QA Specialist – Single Use Systems (SUS)

Location: Hyderabad, India

Job Description Summary:

This role exists to ensure compliance with cGMP and global regulatory requirements by providing quality guidance and oversight for Single Use Systems (SUS) across Lonza’s manufacturing network. Acting as the voice of Global QA, the position drives strategy, execution, and implementation of SUS standards, ensuring alignment with global quality frameworks. The Senior QA Specialist provides technical expertise, risk management, and documentation support, while representing Lonza in industry forums and supporting audits, inspections, and CAPEX projects.

Key Accountabilities:

• SUA Qualification: Draft and review URS (User Requirement Specification) and QR (Qualification Report) documents for Single Use Assemblies.

• Global Alignment: Collaborate with Global Engineering C&Q/CSV and GQE Internal Teams to harmonize commissioning and qualification standards.

• Supplier Qualification: Coordinate support for supplier qualification processes in growth projects; support process revisions, implementation, and roll‑out into new regions.

• Compliance Oversight: Support senior team members in conducting internal GE compliance activities and enforce adherence to global standards and procedures on CAPEX projects.

• QA Reviews & Approvals: Responsible for QA review and approval of global engineering standards and documents.

• Data Integrity: Uphold Lonza’s data integrity principles; proactively evaluate, identify, and improve data integrity processes.

• Documentation & Governance: Review and approve technical documentation, risk assessments, regulatory responses, and global QMS documents related to SUS and raw materials.

• Audit & Inspection Support: Contribute to audits, inspections, and process qualification activities; support CAPEX project teams in preparation for inspections.

• Industry Engagement: Represent Lonza in technical forums (e.g., Biophorum, Dechema); assess vendor change notifications (VCNs); contribute to global training initiatives and best practices.

• Other Duties: Perform additional tasks as assigned, including regulatory CAPA reports, monthly updates, and quarterly inspection reports.

Required Skills & Competencies:

• Strong knowledge of cGMP and regulatory requirements (e.g., FDA, Swissmedic).

• Expertise in Single Use Systems and raw material management.

• Ability to assess risk and provide technical guidance on deviations, CAPAs, and change controls.

• Strong stakeholder management and collaboration skills across global teams.

• Excellent organizational, documentation, and reporting abilities.

• Experience with supplier qualification, engineering standards, and CAPEX project compliance.

• High attention to detail and commitment to quality standards.

Education & Experience:

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field.

• 5–8 years of experience in Quality Assurance within pharmaceutical or biotech manufacturing.

• Experience in SUS qualification, regulatory compliance, and global QA environments.

• Familiarity with QMS systems and industry technical forums.